GSK secures first lung cancer approval days after US$10.6B Nuvalent acquisition

USA—GSK has secured US approval for Jideytro (zidesamtinib) to treat adults with ROS1-positive non-small cell lung cancer (NSCLC), just days after completing its US$ 10.6 billion acquisition of lung cancer biotech Nuvalent.

The US Food and Drug Administration (FDA) approved Jideytro for adults with locally advanced or metastatic ROS1-positive NSCLC who have previously received treatment with a ROS1 kinase inhibitor.

The approval marks GSK’s first entry into the lung cancer market and gives the British pharmaceutical company an immediate commercial foothold in a targeted oncology segment.

Approval based on Phase I/II data

The FDA based its decision on results from the single-arm Phase I/II ARROS-1 study (NCT05118789).

In the trial, Jideytro achieved an objective response rate (ORR) of 44% among the overall patient population, which included patients with brain metastases and ROS1 resistance mutations.

GSK said Jideytro was specifically designed to address some of the limitations associated with existing treatments for ROS1-positive NSCLC.

These include the development of ROS1 resistance mutations after treatment and inadequate penetration of the blood-brain barrier, which can limit the effectiveness of therapies in patients whose cancer has spread to the brain.

The approval therefore strengthens GSK’s position in a market where treatment options are evolving as researchers seek to overcome resistance and improve outcomes for patients with advanced disease.

Nuvalent acquisition expands GSK’s oncology pipeline

GSK gained the rights to Jideytro and another late-stage lung cancer candidate through its acquisition of Massachusetts-based Nuvalent.

The US$10.6billion transaction, which was announced as part of GSK’s strategy to expand its specialty medicines portfolio, closed on 15 July 2026.

Jideytro will now compete in the ROS1-positive NSCLC market alongside Pfizer’s Lorbrena (lorlatinib), which achieved blockbuster status in 2025.

According to GlobalData analysts, Lorbrena sales are expected to grow at a compound annual growth rate of 8.3% between 2025 and 2032.

Meanwhile, GSK is looking to develop additional opportunities from the Nuvalent portfolio to strengthen its position in lung cancer.

One of these is neladalkib, an ALK-selective tyrosine kinase inhibitor that is currently under FDA review.

The agency is expected to decide on the drug’s marketing application on 27 November 2026.

GSK also acquired NVL-330, a HER2-altered NSCLC candidate that remains in early-stage development and is currently being evaluated in a Phase I clinical trial.

Portfolio diversification

The Nuvalent deal comes as GSK faces the prospect of patent expiries affecting some of its established medicines.

These include Tivicay (dolutegravir), its HIV treatment, which is expected to lose market exclusivity in 2028.

In a previous research note, Jefferies analysts said the Nuvalent acquisition adds assets with the potential to generate substantial returns through long treatment durations and expansion into earlier lines of therapy.

The analysts also identified meaningful revenue opportunities for the acquired portfolio beyond 2030.